Analysts Call Nektar Selloff Unwarranted After Rezpegaldesleukin Durability Data
Off-treatment hair regrowth held in a small group, yet analysts said the Nektar selloff does not change the rezpeg thesis.
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Wave Life Sciences Aligns With FDA on Single Registrational Trial for WVE-006 in AATD
Wave plans a single two-year trial for WVE-006 in AATD after FDA feedback, with a one-year review for possible accelerated approval.
McKesson and Cardinal Health Extend CVS Drug Supply Deals Through 2032
BofA kept Buy ratings, calling the news a clearing event.
Foghorn Therapeutics and Eli Lilly End SMARCA2 Cancer Program After Weak Phase 1 Results, Cut 40% of Staff
Foghorn and Lilly will not advance FHD-909 or their SMARCA2 degrader. Foghorn is cutting about 40% of staff to fund its pipeline into late 2029.
Wainwright Initiates Monte Rosa With a Buy as MRT-8102 Phase 1 Data Arrive
Wainwright cites a $565M enterprise value, cash into 2029, and multiple trials.
Whitehawk Gets a Buy From Stifel as Analysts Bet on a More Stable Cancer Drug
Three ADC trials and cash into 2028 are the setup.
Merck’s HS Data Validates the TL1A Pathway — and Helps Shattuck Labs
Merck’s tulisokibart met its Phase 2b HS goal and will move to Phase 3. H.C. Wainwright sees first anti-TL1A skin data as a class plus for Shattuck.
United Therapeutics Wins Patent Case Against Liquidia’s Yutrepia
A Delaware judge found Liquidia’s Yutrepia infringes United Therapeutics’ PH-ILD patent. Final judgment is next.
HETLIOZ Meets Phase III Endpoint in Delayed Sleep-Wake Phase Disorder; Vanda Plans FDA Filing
If approved, it would be the first FDA-approved medicine for the circadian disorder.
Stifel Puts Buy Rating on Achieve After Manufacturing and Capital Reset
Stifel initiates Achieve Life Sciences at Buy with an $18 target, citing a manufacturing, leadership, and capital reset ahead of a 2026 NDA resubmission.
Citi Says Moderna Looks Too Expensive After Cancer-Vaccine Rally
Citi says Moderna’s rally after the INTerpath-001 melanoma win pushed its market value near Regeneron’s despite weaker near-term earnings.
FDA Warns Neogen After Contaminated ‘Sterile’ Horse Product Linked to Dozens of Deaths
FDA warned Neogen after HYCOAT, sold as sterile, was tied to fungal infections and horse deaths. Nearly 100 cases; at least 20 euthanized.
Invivyd’s LIBERTY Win Wasn’t Enough to Hold the Rally
VYD2311 looked better tolerated than Comirnaty, but combo stats were mixed. Shorts, profit-taking, and a crowded COVID market weighed on IVVD.
Novo Pays Up to $2.6 Billion for a Once-Weekly Weight-Loss Pill
The deal adds HRS-1596 to Novo’s pipeline as Lilly, daily pills and other oral GLP-1s intensify competition in obesity and diabetes.
Iovance Raises 2026 Revenue Guidance Above Street as Amtagvi Demand Holds Up
Iovance lifts 2026 revenue guidance to $410–$420 million on strong Amtagvi demand, beating most Street estimates.
uniQure Shares Slump as AMT-130 Benefit Looks Weaker at Four Years
AMT-130 slowed Huntington’s 44% at four years, but the result lost statistical significance after stronger three-year data. Stock falls as FDA review begins.
AstraZeneca Bets $2 Billion on Summit’s Dual-Target Cancer Drug
Summit and AstraZeneca will co-develop ivonescimab combinations, starting with GI cancers. Each company keeps rights to its own medicines.
Lilly Will Spend Obesity Profits on Bigger “White Space” Deals, CEO Says
Eli Lilly CEO Dave Ricks says obesity-drug cash will fund slightly larger buys in sleep, cancer, brain disease, and other underserved science.
Lexicon Surges as Cantor Sees an Unencumbered Path in HCM
Cantor initiates LXRX Overweight with an $8 target on sotagliflozin’s fully enrolled Phase 3 SONATA-HCM trial and a Q1 2027 readout.
Jefferies Initiates Q32 Bio at Buy With $29 Target on Alopecia Potential
The firm points to bempikibart in severe alopecia, a 1H 2027 Phase 3 start, and a stronger cash runway.
4DMT’s 4D-150 Moves Into Phase 3 for DME, Intensifying Pressure on Ocular’s AXPAXLI
4D-150 is now in Phase 3 for DME after two-year SPECTRA data showed durable vision gains and fewer injections, expanding the race with implants like AXPAXLI.
Lifecore Biomedical to Be Acquired by Webster Equity Partners for $6.28 a Share Plus Contingent Payments
Total value can reach about $664 million if 2028–2030 targets are met.
MediciNova Shares Fall After Mixed Phase 2 Results for Fatty Liver Drug MN-001
MediciNova fell after mixed Phase 2 data for MN-001. HDL rose, but week-24 liver fat and triglycerides missed significance in 40 patients.
Kodiak’s Zenkuda Meets Phase 3 Goal in Wet AMD, With More Than Half of Patients on Six-Month Dosing
Zenkuda was non-inferior to Eylea in vision, dried fluid quickly, and put 54% of wet AMD patients on 24-week dosing under strict treat-to-dryness rules.
Nektar Wins $90 Million Verdict Against Eli Lilly Over Rezpeg Partnership
California jury found Lilly breached good faith in the 2017 rezpeg deal and awarded Nektar $90 million plus interest. Lilly plans to appeal.
Guggenheim Raises Damora Price Target to $60 on Bigger Myelofibrosis Outlook
Guggenheim named Damora a Best Idea, citing the potential for earlier, longer mCALR treatment to expand the myelofibrosis and essential thrombocythemia markets.
B. Riley Initiates Precigen at Buy as Papzimeos Launch Gains Steam
B. Riley rates Precigen Buy on Papzimeos, the first FDA-approved adult RRP therapy, plus Q2 profit and management’s year-end cash break-even goal.
Seaport Gets Strong Buy as GlyphAllo Data Looms in 2027
The Glyph pipeline, 2027 catalyst, and cash runway into 2029 drive the case.
Prime Medicine Gets FDA Clearance to Start Human Testing of PM647 for Alpha-1 Antitrypsin Deficiency
First human data are due in 2027. This is not an approval; Beam remains ahead in patients.
Cullinan Stock Drop: Timeline Shift, Sector Selling, and Q4 Catalysts
A missed Q3 RA readout, sector pressure, and high short interest hit CGEM. Cash still funds operations into 2029. Next data: November and December.
Goldman Sachs Starts Sagimet at Sell, Sees 35% Downside Into AURORA
The bank says AURORA endpoints and teen compliance may not match China’s Phase 3 results.
FDA Approves Lilly’s Once-Weekly Insulin Onswik, Challenging Novo’s Awiqli
FDA clears Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes. It may cut 300+ shots a year and now competes with Novo’s Awiqli.
Acadia’s Alzheimer’s Psychosis Drug Missed Its Main Goal. Phase 3 Continues Anyway.
Acadia’s remlifanserin narrowly missed its Phase 2 primary endpoint in Alzheimer’s psychosis. Safety remained favorable, Phase 3 is continuing, and the stock sold off first.
Mesoblast Gets FDA Nod for Extra Quality Check on Ryoncil
Mesoblast received FDA approval for a new TIBA assay to check strength and stability of every commercial Ryoncil batch as manufacturing scales.
FDA Signs Off on aTyr’s Revised Phase 3 Plan in Pulmonary Sarcoidosis
After EFZO-FIT missed, aTyr has FDA alignment on a narrower Phase 3 using FVC. Cash funds operations into 2028, but not the new trial.
Galleri Cancer Blood Test Wins Mixed but Favorable FDA Panel Vote
FDA panel endorsed GRAIL’s Galleri as an add-on cancer blood test. Approval is not final. Coverage, labeling, and whether it saves lives remain open.
New Arcturus Data Supports Liver mRNA Platform as Company Advances Faster Path for Improved OTC
Arcturus shares positive OTC deficiency Phase 2 findings, plans to add ARCT-2601 by year-end 2026, and acquires AI firm myNEO.
Rapport Therapeutics Shares Fall After CEO Comments on RAP-219 Bipolar Mania Trial
Shares of Rapport Therapeutics dropped after conference remarks on RAP-219’s bipolar mania study, weeks before the planned October readout.
Gene-Editing Stocks Fall After Anthropic Says Claude Found a CRISPR-Like Enzyme System
Early lab results show Claude found a CRISPR-like repeat array tied to a reverse transcriptase. No proven editing tool yet.
ORKA Drops After Encouraging Week 28 Data as Investors Take Profits
Analysts called the readout in line with base case. Next tests: 52-week EVERLAST-A in December and EVERLAST-B data in Q4.
Nektar Shares Slide as Jury Weighs Lilly Lawsuit Over Rezpeg
Investors are watching liability and damages in Nektar’s breach case against Lilly, a key swing factor for the Rezpeg program. Analysts still see damages as the hard issue.
Immunovant Ends Cutaneous Lupus Study After IMVT-1402 Fails to Beat Placebo
Immunovant ends IMVT-1402 in cutaneous lupus after a 57-patient study missed its CLASI-A primary endpoint. Other programs remain on track.
Guggenheim Upgrades Editas Medicine to Buy on EDIT-401 Cholesterol Therapy
Guggenheim raised Editas Medicine to Buy with a $5 target, citing EDIT-401’s potential in high-LDL ASCVD patients as its first human trial nears.
Roche and Ionis Report Phase 3 Proteinuria Win for Sefaxersen in IgA Nephropathy
Roche-Ionis sefaxersen beat placebo on proteinuria at week 37 in IgAN Phase 3. Monthly shot enters crowded market vs Novartis Fabhalta.
Cantor Fitzgerald Upgrades Omeros to Overweight After Stronger Yartemlea Launch
Doctors see 35%–40% U.S. share; peak sales estimate raised to about $400 million.
FDA Clears TriSalus’ TriNav Advance for Hard-to-Reach Liver Tumors
FDA clears TriSalus’ TriNav Advance, designed to push more treatment into liver tumors and less into healthy tissue via a SmartValve.
BoomRay Signs Exclusive $900 Million Radioligand Deal With Novartis
Chinese biotech BoomRay licenses a preclinical radioligand therapy to Novartis in a deal worth up to $900 million plus royalties.
Amgen Drug Succeeds in Late-Stage Sjögren’s Disease Trial
Amgen’s dazodalibep met its Phase 3 goal in moderate-to-severe Sjögren’s disease, showing lasting improvement in systemic activity. A second trial is due later in 2026.
Vertex Inaxaplin Data Expands AMKD Market and Lifts Maze Outlook
Truist calls Vertex’s Phase 2b inaxaplin data a validation of APOL1 inhibition in AMKD and sees a 100,000+ extra patient opportunity, plus positive readthrough for Maze.
Lexeo Acquires Mantle for $8.3 Million to Expand Friedreich Ataxia Pipeline
Deal adds oral and brain-targeted FA treatments to Lexeo’s pipeline. LX2006 gene therapy stays top priority, with pivotal data due in late 2027.
Filana Gets FDA Green Light for Phase 2a Simufilam Study in TSC-Related Epilepsy
FDA lifted the clinical hold on Filana’s simufilam, clearing a Phase 2a study in TSC-related epilepsy. Lucid Capital keeps a Buy rating and $8 target.
Compass Therapeutics Slides After FDA Requests New Survival Trial for Tovecimig
Compass disagrees with the FDA, but markets sold off after the agency said existing ORR and PFS data are not enough for a tovecimig filing.
High Complete-Response Rates, Thin Safety Detail, Tough Competition: Celldex’s CSU Readout
Barzolvolimab met every Phase 3 CSU goal, with 42–54% complete responses. Shares still fell on high expectations, thin safety detail, and oral/injectable rivals.
VKTX Jumps After Viking Shows Monthly and Every-Other-Week Shots Can Hold Most Weight Loss
Viking reported 16–19% weight loss at week 21 and strong maintenance on monthly dosing. GI side effects in the later phase looked like placebo.
Labcorp and Quest Slide as CMS Moves to Cut Lab Test Payments in 2027
CMS says Medicare pays 16% more than private insurers for lab tests. Preliminary 2027 rates could save $1B a year, with cuts capped at 15%. Craig-Hallum flags code confusion at GeneDx, Adaptive and Myriad, but says the WGS drop looks overdone.
Revenue Beat and Packed Calendar Lift ANAB After Earnings
AnaptysBio climbed in premarket after a $27.5M collaboration-revenue beat. Jemperli sales grew 26–34%; ignore the $5.11 EPS tax gain.
Grail Stock Jumps as FDA Papers Signal Galleri Panel Path
FDA posted Galleri briefing papers with no leftover lab-test questions. Panel meets Sept. 23; approval odds remain in focus.
Alkermes Calls ADHD Drug a Potential “Company Changer” After Phase 1b Results
Alkermes said ALKS 7290 improved adult ADHD scores in 14 days and was generally well tolerated. Phase 2 data are expected in 2027.
BofA Upgrades Candel Therapeutics to Buy as Prostate Cancer Filing Nears
Prostate data look filing-ready, cash is $201.6M, and analysts see ~66% upside.
Barclays Calls Helus Pharma’s Friday Selloff a Buying Opportunity After $35 Initiation
Helus Pharma sold off Friday after Barclays’ $35 initiation. The bank says APPROACH data are not the sole basis for its rating.
B. Riley Would Be ‘Aggressive Buyers’ of Cue Biopharma After 24% Selloff on Strong CUE-221 Data
Phase 2 CSU data favored CUE-221 over placebo and Xolair. Missing IgE/PK results and a late fade drove a 24% drop. B. Riley: Buy, $83 PT.
Novo Shares Slide as Long-Term Goals Disappoint Market
Distant 2030 goals failed to ease concerns over patents and Lilly.
Xenon Pauses Depression Trials After Safety Signal; Stock Slides
Xenon paused new MDD and BPD enrollment after a psychiatry safety review; X-NOVA2 data expected Q1 2027.
FDA Approves First Gene Therapy for Kids With Sanfilippo Syndrome Type A
The FDA approved Ultragenyx’s Fayuvi for Sanfilippo syndrome type A following a manufacturing-related delay in 2025. Children ages 2–5 who received the treatment maintained or improved their cognitive scores.
Novo: EU backing for new haemophilia treatment plus $1.4bn oral-drug pact
CHMP recommends FREHEMGO (denecimig) for haemophilia A, with or without inhibitors. Novo and Orbis will develop oral cardiometabolic drugs.
Nuvation Bio’s IBTROZI Label Now Shows More Than Four Years of Response
FDA approved an IBTROZI label update showing 49.7 months median response in TKI-naïve ROS1+ lung cancer. Safety language was unchanged.
Qiagen Sale Speculation: KKR, EQT and the $50 Question
Qiagen reviews options with Goldman and Moelis.
Roth Capital Starts MediciNova at Buy With $6 Target on ALS Drug
Phase 2b/3 ALS data due Q4 2026; cash runway into late 2027.
Longeveron to Explore All Options After Phase 2b Failure in Rare Pediatric Heart Condition
ELPIS II missed its primary endpoint in HLHS. Longeveron plans an FDA talk, cost cuts, and a strategic review as cash runs into Q4 2026.
Twist and Ginkgo Join Lilly’s TuneLab to Speed Antibody Discovery With AI and Lab Data
Twist Bioscience and Ginkgo Datapoints join Eli Lilly’s TuneLab to pair lab testing with AI for faster antibody drug discovery.
Barclays Upgrades Alvotech to Overweight, Doubles Target to $8 Ahead of December FDA Decisions
Barclays now sees two-times upside vs. downside for ALVO into December FDA reviews of Simponi, Eylea and Prolia biosimilars.
Xenetic and Santersus Combine to Build a Nasdaq Company Targeting Neutrophil Extracellular Traps
NucleoCapture and DNase will target NETs in sepsis, lupus, transplant and lymphoma.
Needham Upgrades Rocket Pharmaceuticals After FDA Clears Path for Danon Gene Therapy Trial
FDA let Rocket keep its 12-patient Danon study and count the first 3 patients. Needham upgraded RCKT and removed a key regulatory overhang.
Tempest Adds Second In-Vivo CAR-T Approach with Senlang Deal
Tempest gets an exclusive option to license Senlang’s CD7-targeted lentiviral in-vivo CAR-T, now in Phase 1 for relapsed multiple myeloma.
Ascendis Pharma Stock Drops After Ending Novo Partnership
Ascendis will develop TransCon obesity and cardiometabolic programs itself after ending its Novo collaboration and starting a $400M buyback.
GTBP’s Myeloma Headline Was Weaker Than It Sounded
FDA cleared a grant-dependent myeloma IND for GTB-5550. Cheap preferred, 100% warrants, and a tiny float explain the selloff.
Alignment Healthcare Slides After Conference Comments on Stars, Costs, and Ratings Uncertainty
Management cited Star-rating limits, HEI frustration, and a small cost rise.
GSK Buys Experimental Multiple Myeloma Drug from Chimagen
GSK will buy a Chimagen trispecific T-cell engager for multiple myeloma. Phase I trials start in 2027. The deal is worth up to $750 million.
BioVie Shares Fall After Mixed Phase 2 Long COVID Results for Bezisterim
Phase 2 ADDRESS-LC missed statistical significance overall. 21 of 22 measures favored bezisterim; benefits were strongest in severe-symptom subgroups.
H.C. Wainwright Upgrades Cardiff Oncology After Nerviano Settlement Clears Onvansertib Path
The catalyst: an out-of-court deal that keeps exclusive rights to onvansertib. Cash remains tight.
Berenberg Sees 25% Upside in Eli Lilly as Obesity Drugs Keep Winning
Berenberg upgraded Eli Lilly from Hold to Buy and lifted its target to $1,400, citing obesity-drug leadership and a likely 2026 guidance beat.
Vera’s Trutakna Slows Kidney Decline in Two-Year IgAN Trial
Vera’s Trutakna kept kidney function nearly stable over two years in IgAN, cut serious progression risk, and will support a full FDA filing.
Veracyte Buys Convergent Genomics for Up to $180 Million, Adding a Urine Test for Bladder Cancer
Veracyte acquired Convergent Genomics for $150M cash plus up to $30M in milestones, adding UroAmp, a urine tumor DNA test for bladder cancer.
Sionna Moves SION-451 + SION-2222 Into Phase 2a After August Setback
Sionna will start a Q1 2027 Phase 2a trial of SION-451 plus SION-2222 after a missed Trikafta add-on study. A 46% staff cut extends cash into 2H 2029.
Cellectis Drops Blood-Cancer CAR-Ts; Citizens Cuts Rating
Citizens cut Cellectis to Market Perform after it scrapped allogeneic CAR-T programs and pivoted to in-vivo gene editing for high triglycerides and cholesterol. Catalysts now 2027–28.
Contineum’s J&J-Partnered Depression Drug Misses Phase 2 Goal
Contineum said its J&J-partnered drug PIPE-307 missed the Phase 2 primary goal of improving MADRS scores at Day 5 versus placebo.
Johnson & Johnson Weighs $20 Billion Sale of Its Orthopedics Unit to Apollo
J&J is in talks to sell DePuy Synthes, its $9.3B hip-and-knee unit, to Apollo for about $20B. A deal could close in weeks—or J&J may spin it off.
GE HealthCare Eyes Sofie Biosciences Acquisition to Expand Imaging Chemicals
GE HealthCare is considering a deal worth up to $1 billion for Sofie Biosciences, which makes radiopharmaceuticals used in cancer PET scans.
GSK posts strong lung cancer data at WCLC as it seeks first-line Jideytro approval
Jideytro shrank tumors in 94% of untreated ROS1 patients; Ris-Rez cut death risk 54% vs topotecan in China. FDA filing planned this year.
B. Riley Turns Bullish on Capricor Before November Deramiocel Decision
B. Riley upgrades Capricor to Buy from Neutral and lifts its target to $21 from $5 ahead of the Nov. 22, 2026 deramiocel FDA date.
FDA Grants Breakthrough Therapy Designation to Armata’s Phage Therapy for Complicated Staph Blood Infections
FDA awards Breakthrough Therapy designation to Armata’s AP-SA02 for adjunct treatment of complicated staph bacteremia, including MRSA.
Definium Reports Third Phase 3 Win for Fast-Dissolve LSD Therapy
Definium’s DT120 ODT LSD tablet cut GAD anxiety scores 5.1 points vs placebo in Phase 3. Effects started by day 2. FDA filing targeted for 2027.
BioNTech Drug Nearly Doubles Survival in Hard-to-Treat Lung Cancer
Updated PRESERVE-003 data: gotistobart showed 18.5 vs 10 months median survival vs chemo in previously treated squamous NSCLC. Pivotal stage ongoing.
Ivonescimab Cuts Death Risk 27% vs Keytruda, With Strongest Gain in High PD-L1 Patients
HARMONi-2: Summit’s Ivonescimab extended median survival by 8.2 months vs Keytruda. 42% lower death risk in PD-L1-high patients.
Citi Calls Olema Drop After AstraZeneca Trial Miss a Buying Opportunity
Citi calls Olema’s drop after AstraZeneca’s SERENA-4 miss excessive, keeps Buy and $59 target, and sees $20 value from later-line use.
FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
AstraZeneca’s Etcamah Combination Falls Short of Statistical Significance in SERENA-4
The Phase III SERENA-4 trial did not meet its primary PFS endpoint in untreated advanced ER-positive, HER2-negative breast cancer, despite a numerical benefit.
FDA Approves First Treatment for Children Ages 4–11 With Rare Immune Disease APDS
The FDA has approved Pharming’s Joenja as the first U.S. treatment for children ages 4–11 with APDS who weigh at least 27 kg.
Auvelity’s Early Alzheimer’s Agitation Launch Draws Bullish Analyst Notes
Mizuho, Needham and Guggenheim cite 32–34% script growth and robust 65+ uptake as Auvelity’s Alzheimer’s agitation launch gets off to a strong start.
JPMorgan Puts $135 Target on Dianthus After Starting Coverage
Lead drug claseprubart (also known as DNTH103) plus $1.2B cash into 2030.